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The clinical performance of the acuvue, NewVues, and SeeQuence disposable contact lenses in patients with giant papillary conjunctivitis
The Clinical Performance of the Acuvue, NewVues, and SeeQuence Disposable Contact Lenses in Patients With Giant Papillary Conjunctivitis Frank A. Bucci, Jr., MD,
Marta 0. Lopatynsky,
Disposable contact knses worn on a daily-wear basis have been effective in managing patients with giant papillary conjunctivitis. The purpose of this study was to determine which of the available disposable contact lenses, Acuvue (Vistakon, Jacksonville, FL), NewVues (CUBA Vision, Atlanta, GA), and SeeQuence (Bausch B Lomb, Rochester, NY), is superior for managing giant papillary conjunctivitis. Forty-two patients with previously diagnosed giant papillary conjunctivitis were enrolled and monitored at I-month intervals for 5 months in a prospective, randomized, dot&e-masked study to evaluate the Acuvue, NewVues, and SeeQuence disposabkz contact lens worn on a daily-wear basis for I month between lens changes. A detailed analysis of patient preferences with regard to eight symptom variables (itching, discharge, blurred vision, pain, abnormal fens movement, lens awareness, lens handling, and lens comfort, and their overall lens preference was performed monthly. Multivariate regression analysis was performed. When SeeQuence was paired with Acuvue, SeeQuence was preferred for lens movement (p = 0.0002) and lens handling (p = 0.0005); Acuvue was preferred for itching (p = 0.037). When SeeQuence was paired with NewVues, NewVues was preferred for itching (p = .022), blurred vision (p = 0.042), pain (p = 0.029), comfort (p = 0.030), and overall (p = 0.024). When Acuvue was paired with NewVues, NewVues was preAddress reprint requests to Frank A. Bucci, Jr., MD, 166 Mt. Airy Road, Shavertown, PA 18708. Accepted for Publication
November
18, 1994.
ICLC, Vol. 22, March/April, 1995 0 Elsevier Science Inc. 1995 655 Avenue of the Americas, New York,
NY 10010
MD, and Peter Zloty, MD
ferred for lens handling (p = 0.028). Multivariate regression analysis revealed that, of the eight symptom variables tested, lens comfort and kns handling contributed significantly to the overall lens preference in all three paired studies. Lens comfort was at least twice as powerful as lens handling in all cases. No significant changes in papike were observed. In conclusion, the NewVues outperformed the SeeQuence kns in numerous clinical categories, including overall lens preference. NewVues was significantly preferred over Acuvue only with regard to lens handling. The NewVues was never outperformed.Lens comfort was the most powerful of eight variablescontributing to the decisionsregardingoverall lenspreference. Keywords Giant lenses; Acuvue; evaluation
papillary conjunctivitis; NewVues; SeeQuence;
disposable contact patient preference
Introduction Giant papillary conjunctivitis (GPC) is a well-known clinical condition affecting a conservatively estimated 1 to 5% of the 25 million contact lens wearers in the United States.’ The signsand symptomsof GPC include itching, excessive mucous discharge, contact lens intolerance, blurred vision, and a papillary reaction of the upper tarsal conjunctiva.
The authorshave no proprietaryinterestin any of the products discussed in this report and have received no external sources of funding. 0892-8967/95/$10.00 SSDI 0892-8967(94)00012-6
Disposable Contact Lenses in Patients With GPC: Bucci et al. The exact cause of GPC is unknown. There is growing evidence that both the antigens in contact lens deposits2 and conjunctival trauma3,4 from contact lensesstimulate relatively independent inflammatory reactions in this condition. This suggests that an effective strategy for managing GPC would include the useof contact lensesthat minimize both conjunctival trauma and contact lens deposits.When the frequent replacement of disposable contact lenses is combined with daily-wear use, this strategy can be implemented. We have recently reported in a controlled study5 that the Acuvue (Vistakon, Jacksonville, FL) disposablecontact lens was equally effective in managing GPC when compared with the traditional daily-wear lens of choice (CSI; Pilkington Barnes Hind, Sunnyvale, CA). Becausethe effectivenessof a disposablelensworn on a daily-wear basishas been established,the purposeof this study wasto determine which of the available disposablecontact lenses,Acuvue, NewVues, or SeeQuence, is superior for managing GPC.
Methods Forty-two patients with previously diagnosedGPC were enrolled and monitored at l-month intervals for 5 months in a prospective, randomized, double-maskedstudy. Criteria for exclusion from the study included the presenceof other ocular diseases,the regular useof ocular medications, the use of systemicsteroids,the useof systemicnonsteroidal anti-inflammatory medications, and the use of cromolyn sodium within 4 weeks of enrollment into the study. Enrolled patients were instructed not to use ocular medications throughout the study. Patients in Group I received an Acuvue lens (etafilcon A with 58% water) in one eye and a SeeQuence lens (polymacon with 38.6% water) in the other eye. Group II received a NewVues lens (vifilcon A with 55% water) and a SeeQuence lens. Patients in Group III received an Acuvue lens in one eye and a NewVues in the other eye. All lenses were usedon a daily-wear basisfor a period of 1 month. A uniform systemof lens care was provided for each patient. The AOSEPT@ cleaning and disinfecting system and weekly Ultrazyme@ enzymatic applications were used. Patients were not specifically asked to discontinue contact lens use just before the commencement of the study. The diagnosisof GPC wasconfirmed at the initial meeting with each patient. An ocular and contact lens history wasobtained, and an examination wasperformed. Patient histories included the collection of data concerning the patients’ age, sex, years of soft contact lens use, yearssince diagnosisof GPC, the ageof their present lenses,the hours of contact lens use, their history of allergies, and their history of topical cromolyn sodium use. The everted upper lid was evaluated at the baseline examination and at the third and fifth follow-up visits. Papillae were ranked from 1 to 7 according to their size and distribution. The grading systemfor evaluating the papillae
Table 1. Patient Profileof GPC PatientsEnteringDisposable Contact LensStudy
Age Sex Yearsof soft contact lensuse Yearssincediagnosis of GPC Age of present contact lenses Hoursof contact use History of allergies History of topical cromolynsodiumuse
Average 31.0 years Range 19-39years Male, 11 Female,31 Average 7.3 years Range 2-16 years Average 2.1 years Range O-5 years Average 9 months Range 1 month-3 years Average 11.4hours Range G-20 hours 10%seasonal allergies 25%drug allegies(i.e. ( penicillin) 27%
on the everted upper lid wasthe following: Grade 1, normal examination; Grade 2, initial formation of macropapillae (0.3-1.0 mm); Grade 3, diffuse macropapillae (0.3-1.0 mm) and initial formation of giant papillae (larger than 1.0 mm); Grade 4, diffuse macropapillae (0.3-1.0 mm) and giant papillae (larger than 1.0 mm) covering most of the lower one-third of the everted upper lid; Grade 5, giant papillae (larger than 1.O mm) covering most of the lower two-thirds of the everted upper lid; Grade 6, diffuse giant papillae (larger than 1.0 mm); Grade 7, giant papillae (larger than 1.0 mm) observablewith the naked eye. Ocular examinations were performed by an independent masked examiner after the contact lenses had been removed. Patients were unaware that they were wearing disposablecontact lenses.The patient was informed that his or her lenseswere to be examined at each visit. A new disposablecontact lens was exchanged for the “old” lens before the lens casewas returned to the patient. One lens casewasusedfor the duration of the study. At each follow-up visit, a questionnaire called “a patient preference evaluation” was completed. This questionnaire tested patient preferenceswith regard to nine variables including itching, discharge, blurred vision, pain, abnormal lens movement, lens awareness,lens handling, lens comfort, and overall lens preference. Patients were given the choice of having no preference (Pref.) or a mild, moderate (Mod.), or strong preference for either contact lens. For example, the patient wasaskedto respondto the following statement: “With regardto itching, I prefer the Left Lens
SrAla
Mid.
Mild
?I” Prei.
5 Mdd
6 Mod.
.” 7 Strong
Rtght LSXS
After the patient had respondedto a similar statement for the first eight variables, overall lenspreference wasevaluated by having the patient respondto the following statement:
ICLC, Vol. 22, March/April
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Table 2. Patient Preference Evaluation for Pooled Responses (All Follow-Up Preference response per Lens
Symptoms Itching
Acuvue SeeQuence No preference Acuvue SeeQuence No preference Acuvue SeeQuence No preference Acuvue SeeQuence No preference Acuvue SeeQuence No preference Acuvue SeeQuence No preference Acuvue SeeQuence No preference Acuvue SeeQuence No preference Acuvue SeeQuence No preference
Discharge
Blurred vision Pain Lens movement
Lens awareness Handling
Comfort Overall
25 10 23 10 6 42 16 14 28 16 16 26 4 19 35 15 23 20 5 26 27 17 21 21 25 12
Visits): Acuvue vs. SeeQuence (N = 58) (Group I) Mean’ Rank
Two-Tailed p Value
17.70 18.75
0.0371
Acuvue
08.10 09.17
0.501
-$
14.41 16.75
0.967
-4
14.81 18.19
0.614
-4
11.25 12.16
0.047t
SeeQuence
20.83 18.63
0.400
-4
14.10 16.37
0.001t
SeeQuence
21.62 17.79
0.965
4
24.45 22.70
0.768
-4
Preferred Lens
Wilcoxon matched-pairs signed-ranks test. t Significant. $ No significant difference between lenses. l
“Overall, Left Lens
with all things considered,
1 Strong
2 Mod.
3 Mild
4 No. Pref.
5 Mild
I prefer the . 6 Mod.
7 Strong
.” Right Lens
The data from the patient preference evaluations were analyzed both parametrically and nonparametrically. The Kolomogorov-Smirnov one-sampletest was used to assess the normal distribution of the data. The pooled data easily met the requirements of this test, whereasthe data from individual follow-up visits were borderline. The patient preference evaluation wasanalyzed for each group at every follow-up visit and in the aggregate. The more powerful parametric one-samplepaired t-test was applied to screen for significant differences in the data. The nonparametric Wilcoxon matched-pairssigned-rankstest wasthen usedto confirm the detection of true differences while meeting the strict criteria required with ordinal scaleddata. Multivariate regressionanalysis was also performed on the patient preference evaluation data. The first eight symptom characteristics acted as the independent variables, whereasoverall lens preference acted as the dependent variable. Numerous methods of analysis were applied to detect significant differences in the data regarding the examina-
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tion of the papillae of the everted upper lids. First, the data for each lens type for each individual group were compared at baseline, at the third follow-up visit, and at the final follow-up visit (5 months). Thus, nine paired-samples t-testswere completed, one t-test for each of three groupsat three different time periods. The parametric t-test wasthen followed by a nonparametric Wilcoxon test to confirm the results becausethe parametric tests are dependent on a normal distribution of the data. The examination data for each lens type from each group were analyzed for changesover time. The examination data were then restructured to allow analysisby lens type, irrespective of group. For example, the examination data for eyes wearing the Acuvue lens from Groups I and III were combined into one group of all eyes wearing the Acuvue lens. Thus, analysisin the aggregateto compare all “Acuvue eyes” with all “NewVues eyes” and “SeeQuence eyes” waspossible.A regressionwasperformed for each lens type to test the hypothesis that the slopeof the regressionline of papillae gradingsasa function of the time period waszero.
Results Randomization resulted in Group I (Acuvue YS. SeeQuence) having 12 patients, Group II (NewVues ets.
Disposable Contact Lenses in Patients With GPC: Bucci et al. Table 3. Patient Preference Evaluation Symptoms Itching
Discharge Blurred vision Pain
Lens movement Lens awareness Handling Comfort Overall
for Pooled Responses (All Follow-Up
Preference response per Lens SeeQuence NewVues No preference SeeQuence NewVues No preference SeeQuence NewVues No preference SeeQuence NewVues No preference SeeQuence NewVues No preference SeeQuence NewVues No preference SeeQuence NewVues No preference SeeQuence NewVues No preference SeeQuence Newvues No preference
20 31 21 15 18 39 23 27 22 16 27 29 18 18 36 27 30 15 27 17 28 23 35 14 24 36 12
Visits): SeeQeunce vs. NewVues
(N = 72) (Group II)
Mean’ Rank
Two-Tailed p Value
21.13 29.15
0.024t
14.43 19.14
0.252
-4
18.96 31.07
0.050t
NewVues
19.38 23.56
0.049t
NewVues
14.97 22.03
0.318
-4
25.17 32.45
0.242
-4
21.28 24.44
0.353
4
25.59 32.07
0.039t
NewVues
25.42 33.89
0.0251
NewVues
Preferred Lens NewVus
Wilcoxon matched-pairs signed-ranks test. t Significant. $ No significant difference between lenses. l
SeeQuence) having 15 patients, and Group III (NewVues vs. Acuvue) having 15 patients. The number of patients lost to follow-up wasnot a significant problem. No patients were lost to follow-up in Groups I and II until the last follow-up visit. Only two patients in Group I and three patients in Group II were not evaluated at the last followup visit. No patients were lost to follow-up in Group III through three visits. Two patients were lost to follow-up at Visit 4, and one was lost to follow-up at Visit 5 in Group III. Patient profiles are summarizedin T&k 1. Trends toward correlations between both the age of the present contact lens and the hours of contact lens usewith the severity of symptoms were observed, but significance was not demonstrated. No episodesof acute GPC were observedthroughout the study. There were no episodesthat necessitatedthe useof topical medications. The total number of tom contact lenseswas nine for the Acuvue, two for the SeeQuence, and five for the NewVues. The patient preference evaluations revealed significant differences between lensesin all three groups. Pooled data from all follow-up visits in Group I (Acuvue versus SeeQuence) showed mixed results (Table 2). The Acuvue
wassignificantly preferred to the SeeQuencefor itching (p = 0.037). For abnormal lens movement (p = 0.047) and lens handling (p = O.OOl), the SeeQuence was significantly preferred to the Acuvue. There was no significant difference for overall lens preference between the Acuvue and SeeQuencelenses.The preference for the SeeQuence lens with regard to handling wasalsodetected at numerous individual visits. The patients in Group II (SeeQuence vs. NewVues) for the pooled data significantly preferred the NewVues lens for four of eight variables and for overall lenspreference (p = .025) (Table 3). The four variables for which the NewVues lens was preferred were itching (p = 0.024), blurred vision (p = O.OSO),pain (p = 0.049), and lens comfort (p = 0.025). These differences were also detected in the analysisof early individual follow-up visits. Group II wasthe only paired study that revealed a significant difference for the overall lens preferencevariable (NewVues preferred to SeeQuence). The patients in Group III (Acuvue vs. NewVues) significantly preferred the NewVues lenswith regardto lens handling (p = 0.024) in th e analysisof the pooled data (Table 4). No significant difference for overall lens preference was detected between the Acuvue and NewVues lenses.
ICLC, Vol. 22, March/April
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83
Clinical Article Table 4. Patient Preference Evaluation for Pooled Responses (All Follow-Up Preference response per Lens
Symptoms Itching
AcuVue NewVues No preference AcuVue NewVues No preference AcuVue NewVues No preference AcuVue NewVues No preference AcuVue NewVues No preference AcuVue NewVues No preference AcuVue NewVues No preference AcuVue NewVues No prefernce AcuVue NewVues No preference
Discharge Blurred vision Pain Lens movement Lens awareness Handling
Comfort Overall
Visits): Acuvue vs. NewVues
(N = 70) (Group III)
Mean’ Rank
Two-Tailed p Value
Preferred Lens
13.14 15.38
0.183
--.j
10.72 08.28
0.632
-3
19.62 18.19
0.361
-4
19.23 14.63
0.793
-4
16.75 11.24
0.443
-4
19.09 17.08
0.876
-4
09.42 18.94
0.024t
NewVues
15
23.55 19.80
0.960
-4
:: 22 23 25
28.30 23.79
0.676
--$
8 14 48 6 6 58 18 13 39 10 16 44 5 14 51 13 16 41 9 :::
* Wilcoxon matched-pairs signed-ranks test. t Significant. $ No significant difference between lenses. Multivariate
regression
analysis
revealed
that,
of the
eight variables tested, lens comfort and lens handling contributed significantly to the choice for overall lens preference in all three paired studies (T&b 5). The regression coefficients indicated that lenscomfort wasat leasttwice as powerful as lens handling in all cases.For the Acuvue 01s. NewVues study (Group III), in addition to lens comfort (0.60) and lens handling (0.30), four other variables were detected assignificantly contributing to the choice of overall lens preference. The four variables and their regression coefficients were blurred vision (0.30)) pain (0.22)) abnormal lens movement (0.24), and lens awareness(0.22). In summary, the NewVues outperformed the SeeQuence in five of nine clinical categories, including overall lens preference. When the Acuvue was compared with the SeeQuence, the SeeQuence was preferred for lens movement and lens handling, whereasthe Acuvue waspreferred with regard to itching. The NewVues outperformed the Acuvue in only one category-lens handling. Lenscomfort wasclearly the most powerful variable contributing to overall lens preference, followed most consistently by lens handling. It should be noted that the SeeQuence lens was outperformed with regard to itching in both paired studies. Similarly, the Acuvue wasoutperformed with regard to lens
84
ICLC, Vol. 22, March/April
1995
handling in both of its paired studies. The NewVues lens wasnever outperformed. The frequency of papillae gradingsfor each lens type is summarizedin Table 6. No significant changesin the papillae were observed between lens types at any follow-up visit or over time within each group of lenses.Nine pairedsamplest-tests representinga comparison of gradingsof papillae for each pair of lenses in the three groups at the baseline, 3-month, and 5month evaluations showed no significant differences. These data are summarizedin Tubk 7. These nine groups of ordinal scaled data were then reanalyzed by the use of a nonparametric test called the Wilcoxon matched-pairs signed-rankstest. This test also revealed no significant differences in papillae gradingsbetween lens types at all time periods, and the p values for each Wilcoxon test is given in Table 7 adjacent to the p values for the paired-samplest-tests. The nonparametric three-sample Friedman two-way analysis of variance was used to analyze changes in the papillae gradingsover time for each lens type within each group. Six analysesrepresenting two lens types for each of three groupsrevealed no significant changesover time for any of the six groupstested. The gradingsof papillae were then analyzed by lenstype,
Disposable Contact Lenses in Patients With GPC: Bucci et al. Table 5. Multivariate Regression Analysis for Symptom Variables (Independent Variable) Contributing to the Choice of Overall Lens Preference (Dependent Variable) Group I (Acuvue ws. SeeQuence) Symptom Variables Itching Discharge Blurredvision Pain Lensmovement Lensawareness Lenshandling Lenscomfort
Regression Coefficient
Group II (SeeQuence vs. NewVues) Regression Coefficient
p Value
l
*
0.571
0.0046
0.36t
0.0008
*
-
.
-
l
.
l
*
*
p Value
l
-
.
0.0434
* -
.
0.0381 o.c315 0.0001 0.0001
0.24t l 0.22t
0.27t
O.oool 0.0001
0.54t
0.16t 0.93t
0.0004
0.30t
0.0001
0.60-f
.
- * 0.0001
0.30-f 0.22t
- .
.
-
-
- t
l
l
- *
-
-
Regression Coefficient
p Value
- *
l
Group III ( Acuvue vs. NewVues)
Regression coefficientnot significant. t Regression coefficient indicatesstatisticallysignificantcontribution to the choiceregardingoverall lenspreference. l
Table 6. FrequencyDistributionof PapillaeGradingson EvertedUpperLidsat the Baseline,3-Month, and Final (5-Month) Followup Evaluations Frequencyof PapillaeGradings(%) Lens Twe
Time Period
Grade 1
Grade
Grade
Grade
Grade
Grade
Grade
2
3
4
5
6
7
Mean
SD
SE
Groups
Acuvue Acuvue Acuvue
Baseline 0 (0) 3 months 0 (0) 5 months 0 (0)
0 (0) 0 (0) 0 (0)
1 ( 3.7)
14 (51.9)
6 (22.2)
6 (22.2)
0 (0)
4.63
0.88 0.17
4 (14.8)
10 (37.0)
8 (29.6)
5 (18.5)
0 (0)
4.52
0.98
1 ( 4.5)
11 (50.0)
8 (36.4)
2 ( 9.1)
0 (0)
4.50
0.74 0.16
NewVues NewVues NewVues
Baseline 0 (0) 3 months 0 (0) 5 months 0 (0)
0 (0) 0 (0) 0 (0)
8 (26.7) 8 (26.7) 8 (33.3)
11 (36.7)
7 (23.3)
14 (46.7) 8 (33.3)
5 (16.7) 6 (25.0)
4 (13.3) 3 (10.0)
0 (0) 0 (0)
4.23 4.10
1.00 0.18 0.92 0.17
2 ( 8.3)
0 (0)
4.08
0.97
SeeQuence Baseline 0 (0) SeeQuence 3 months 0 (0) SeeQuence 5 months 0 (0)
0 (0) l(3.7) 0 (0)
5 (18.5)
10 (37.0) 12 (44.4)
8 (29.6) 5 (18.5)
3 (11.1) 4 (14.8)
l(3.7) 0 (0)
4.44
1.05 0.20
4 (18.2)
3 (13.6)
0 (0)
4.22 4.18
1.05 1.05
5 (18.5) 6 (27.3)
9 (40.9)
0.19
0.20 0.20 0.20
I & III I &III I&III II & III 11& III II & III I &II I & II I & II
SD, standarddeviation; SE, standarderror. irrespective of their original group. Nonrepeated and repeatedmeasuresanalysisof variance rejected the hypothesis that significant differences in the meansof papillae gradings between the groups were present. To test for significant changes over time in these three aggregated lens type groups, a regressionanalysis of papillae gradings against time wasperformed for the three lenstypes. The hypothesis that the slopeof the regressionline of papillae gradingsas a function of time is zero was accepted for all three lens groups.
Discussion Although the exact causeof GPC is still unclear, recent studieshave strongly suggestedthat at least two relatively independent pathophysiologic factors are present. First, ocular immune responsesin monkeys wearing lensesfrom patients with GPC suggestthat someantigenic factor in the lens coating induces an immune reaction.2 Second, physical trauma of conjunctival cells induced by contact lenses hasbeen shown to stimulate the releaseof neutrophil che-
motactic factors. 3v4 Symptoms, such as abnormal lens movement, lens awareness,and discomfort on insertion, appear to be closely linked to the physical properties of lenses(i.e., edgedesigns)and their mechanical interaction with the ocular surface and palpebral conjunctiva. The prominent symptom of itching in GPC hasbeen shown to dramatically improve with the introduction of a fresh lens of almost any type, even in the setting of worsening mechanically related symptoms.6These clinical observations support the concept of a multifactorial pathophysiology in GPC. The useof frequent lens replacement and daily lens hygiene in this study minimizes the potential development of symptomatic GPC secondary to the accumulation of contact lens deposits. Thus, this comparative clinical assessment emphasizesthe relationship between the physicalmechanicalproperties of each lens and their ability to function on an ocular surfacepreviously complicated by GPC. The resultsof this study suggestthat the NewVues lens is the disposablelens of choice for patients with GPC. The ICLC, Vol. 22, March/April
1995
85
Clinical
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Table 7. Statistical Comparison Time Period Baseline
3 months
5 months
Baseline
3 months
5 months
Baseline
3 months
5 months
Lens Type
of Papillae Gradings Within Group
Each Group at Baseline, 3 Months, and 5 Months
No. of Patients
Mean
Acuvue
1
12
4.67
SeeQuence
I
12
4.42
Acuvue
I
12
4.42
SeeQuence
I
12
4.25
Acuvue
I
10
4.60
SeeQuence
I
10
4.10
SeeQuence
II
15
4.47
NewVues
II
15
4.20
SeeQuence
II
15
4.20
NewVues
II
15
3.93
SeeQuence
II
12
4.25
NewVues
II
12
4.00
Acuvue
III
15
4.60
NewVues
III
15
4.27
Acuvue
III
15
4.60
NewVues
III
15
4.27
Acuvue
III
12
4.42
NewVues
III
12
4.17
Mean Difference
SD
0.25
1.06
0.43’
(Wilcoxon
= 0.39t)
0.17
1.20
0.64
(Wilcoxon
= 0.78)
0.50
0.97
0.14
(Wilcoxon
= 0.16)
0.27
1.53
0.51
(Wilcoxon
= 0.55)
0.27
1.28
0.43
(Wilcoxon
= 0.41)
0.25
1.36
0.54
(Wilcoxon
= 0.39)
0.33
1.11
0.26
(Wilcoxon
= 0.28)
0.33
1.23
0.31
(Wilcoxon
= 0.30)
0.25
0.97
0.39
(Wilcoxon
= 0.40)
Two-Tailed
p Value
SD, standard deviation. * p value from paired-samples c-tests (parametric). 7 p value from Wilcoxon matched-pairs signed-ranks test (nonparametric). NewVues
lens only
narrowly
outperformed
the Acuvue
lens, and there wasno significant difference for the overall lens preference variable. The clinical performance of the Acuvue lens suggests that a significant number of patients encountered difficulties when trying to manipulate this lens. This is consistent with a previous study that compared the Acuvue lens with the CSI lens in GPC patients. ’ The CSI lenswaspreferred to the Acuvue lens with regard to handling (78 VS.6%) for those patients having a preference. Multivariate regression analysis identified lens handling as a significant variable contributing to overall lens preference in both the CSI study and this study. For this investigation, lens handling was a significant independent variable in all three paired studies. Its power as an independent variable was second only to lens comfort. Although someclinicians may argue that lens handling has no direct relationship with the clinical syndrome of GPC, we believe that this variable may play an important 86
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Vol. 22, March/April
1995
role and should be studied. It is well known that GPC patients should not wear contact lenseson an extendedwear basis.Thus, disposablelenses,which were originally designedasextended-wear lenses,are frequently being used on a daily-wear basisin patients having GPC. Excessive lens manipulation can lead to accelerated soiling of soft contact lenses.Substancesfrom the skin may increasethe antigenic load on the contact lens. Difficulties with lens handling may influence the overall compliance with the practice of quality lens hygiene. Effective lens hygiene is critical in patients with GPC, even when they are wearing disposablelensesfor relatively short wearing intervals. Lenshandling may also influence the rate of tom lenses for each lens type. If we assumethat difficulties with lens handling correlate with increasedrates of tom lenses,then the relatively higher number of tom Acuvue lensesreported in this study is not surprising. Clinicians and patients have both reported that the excessive flexibility of the Acuvue lens can frequently obscure its proper orienta-
Disposabk Contact Lenses in Patients With GPC: Bwci et al. tion before insertion. This characteristic of the Acuvue lens is probably responsiblefor its relatively poor performance with regard to lens handling and the rate of tom lenses.
References 1. Allansmith
MR, Korb DR, Greiner JV, et al. : Giant papillary conjunctivitis in contact lens wearers. AmJ Ophthulmol 1977; 83~697-708. 2. Ballow M, Donshik PC, Rapacy P, et al. : Immune responses in monkeys to lenses from patients with contact lens induced giant papillary conjunctivitis. CLAO 1989; 15&l-70. 3. Ehlers WH, Donshik PC, Gillies C, et al.: The induction of an inflammatory reaction (similar to giant papillary conjunc-
Clinical
tivitis) by chemotactic factors derived from conjunctival cells. ARVO abstract. Invest Ophthulmol Vis Sci 1990;3 I:
(Suppl):241. 4. Elgebaly SA, Donshik PC, Rahhal F, Williams W: Neutrophi1 chemotactic factors in the tears of giant papillary conjunctivitis patients. Invest Ophthalmol Vis Sci 1991;32:208213. 5. Bucci FA Jr, Lopatynsky MO, Jenkins PL, et ~2.: The Acuvue disposable contact lens versus the CSI contact lens in patients with giant papillary conjunctivitis. Am ] Ophthdmol 1993;115:454-459. 6. Bucci FA, Jr, Lopatynsky MO, Jenkins PL, et al. : The deposit resistant Hydrocurve Elite soft contact lens and giant papillary conjunctivitis. ARVO abstracts. Invest Ophthulmol Vis Sci 1989;3O(Suppl):256.
Implications
Disposablecontact lensesworn on a daily-wear basisand replaced every 1 to 2 weeks appear to be effective in managing patients with giant papillary conjunctivitis (GPC). Reducing the protein-related antigens from contact lens deposits and minimizing conjunctival trauma from contact lens wear are reasonablestrategiesfor managing GPC. This article attempts to show that one brand of disposablecontact lens is best in managing GPC. Statistics may show that one brand is preferable; however, clinical performance does not seem to be significantly enhanced by the use of one brand of disposableover the others. The lenseswere usedin a non-Food and Drug Administration-approved method; therefore, the clinical implication may not be asobvious asthe statistics indicate. Knowledge of this researchmay be valuable to keep in mind when selecting a lens for your patient.
ICLC, Vol. 22, March/April
1995
87
Clinical A&k Peter Zloty, MD, is a cornea and external disease specialist currently in private practice in Dothan, AL. He received his medical degree from the Albany Medical College of Union University in Albany, NY. After a medical internship in Albany, he served 3 years as an emergency medicine physician in the United States Navy. Dr. Zloty completed his ophthalmology residency and cornea1 fellowship at the Albany Medical Center in Albany. His cornea1 fellowship was under the direction of Michael W. Belin, MD, and emphasized local and systemic immunosuppression in cornea1 transplantation and ocular inflammatory diseases. He has published two book chapters in ocular infectious diseases. Marta 0. Lopatynsky, MD, is currently the cornea and external disease specialist at Bassett Health Care in Cooperstown, NY. She received a cum laude degree from New York University, received her masters degree from Albany Medical College, and completed an internship and residency at Albany Medical Center. Her fellowship in cornea and external disease was completed at Wills Eye Hospital in Philadelphia. She has received a number of awards including the Outstanding Research Award in 1988 and, in 1990, the CLAO first prize for clinical research. She has authored several articles on contact lens use and penetrating keratoplasties. Frank A. Bucci, Jr., MD, is currently the director of the Center for Contact Lens Research in Kingston, PA. He originally attended Rollins College on a basketball scholarship. He received a masters in health care administration from Cornell University. Dr. Bucci completed his ophthalmology residency at Albany Medical College in Albany, NY. He received his fellowship training in cornea1 transplantation, small incision cataract surgery, and refractive surgery under the direction of Richard L. Lindstrom, MD, at the University of Minnesota. Dr. Bucci was awarded Best Scientific Presentation at the Annual Meeting of the Contact Lens Association of Ophthalmology (CLAO) in 1990 and 1994. He has authored over 25 original publications in peer review journals.
88
ICLC, Vol. 22, March/April
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Marta 0. Lopatynsky,
Disposable contact knses worn on a daily-wear basis have been effective in managing patients with giant papillary conjunctivitis. The purpose of this study was to determine which of the available disposable contact lenses, Acuvue (Vistakon, Jacksonville, FL), NewVues (CUBA Vision, Atlanta, GA), and SeeQuence (Bausch B Lomb, Rochester, NY), is superior for managing giant papillary conjunctivitis. Forty-two patients with previously diagnosed giant papillary conjunctivitis were enrolled and monitored at I-month intervals for 5 months in a prospective, randomized, dot&e-masked study to evaluate the Acuvue, NewVues, and SeeQuence disposabkz contact lens worn on a daily-wear basis for I month between lens changes. A detailed analysis of patient preferences with regard to eight symptom variables (itching, discharge, blurred vision, pain, abnormal fens movement, lens awareness, lens handling, and lens comfort, and their overall lens preference was performed monthly. Multivariate regression analysis was performed. When SeeQuence was paired with Acuvue, SeeQuence was preferred for lens movement (p = 0.0002) and lens handling (p = 0.0005); Acuvue was preferred for itching (p = 0.037). When SeeQuence was paired with NewVues, NewVues was preferred for itching (p = .022), blurred vision (p = 0.042), pain (p = 0.029), comfort (p = 0.030), and overall (p = 0.024). When Acuvue was paired with NewVues, NewVues was preAddress reprint requests to Frank A. Bucci, Jr., MD, 166 Mt. Airy Road, Shavertown, PA 18708. Accepted for Publication
November
18, 1994.
ICLC, Vol. 22, March/April, 1995 0 Elsevier Science Inc. 1995 655 Avenue of the Americas, New York,
NY 10010
MD, and Peter Zloty, MD
ferred for lens handling (p = 0.028). Multivariate regression analysis revealed that, of the eight symptom variables tested, lens comfort and kns handling contributed significantly to the overall lens preference in all three paired studies. Lens comfort was at least twice as powerful as lens handling in all cases. No significant changes in papike were observed. In conclusion, the NewVues outperformed the SeeQuence kns in numerous clinical categories, including overall lens preference. NewVues was significantly preferred over Acuvue only with regard to lens handling. The NewVues was never outperformed.Lens comfort was the most powerful of eight variablescontributing to the decisionsregardingoverall lenspreference. Keywords Giant lenses; Acuvue; evaluation
papillary conjunctivitis; NewVues; SeeQuence;
disposable contact patient preference
Introduction Giant papillary conjunctivitis (GPC) is a well-known clinical condition affecting a conservatively estimated 1 to 5% of the 25 million contact lens wearers in the United States.’ The signsand symptomsof GPC include itching, excessive mucous discharge, contact lens intolerance, blurred vision, and a papillary reaction of the upper tarsal conjunctiva.
The authorshave no proprietaryinterestin any of the products discussed in this report and have received no external sources of funding. 0892-8967/95/$10.00 SSDI 0892-8967(94)00012-6
Disposable Contact Lenses in Patients With GPC: Bucci et al. The exact cause of GPC is unknown. There is growing evidence that both the antigens in contact lens deposits2 and conjunctival trauma3,4 from contact lensesstimulate relatively independent inflammatory reactions in this condition. This suggests that an effective strategy for managing GPC would include the useof contact lensesthat minimize both conjunctival trauma and contact lens deposits.When the frequent replacement of disposable contact lenses is combined with daily-wear use, this strategy can be implemented. We have recently reported in a controlled study5 that the Acuvue (Vistakon, Jacksonville, FL) disposablecontact lens was equally effective in managing GPC when compared with the traditional daily-wear lens of choice (CSI; Pilkington Barnes Hind, Sunnyvale, CA). Becausethe effectivenessof a disposablelensworn on a daily-wear basishas been established,the purposeof this study wasto determine which of the available disposablecontact lenses,Acuvue, NewVues, or SeeQuence, is superior for managing GPC.
Methods Forty-two patients with previously diagnosedGPC were enrolled and monitored at l-month intervals for 5 months in a prospective, randomized, double-maskedstudy. Criteria for exclusion from the study included the presenceof other ocular diseases,the regular useof ocular medications, the use of systemicsteroids,the useof systemicnonsteroidal anti-inflammatory medications, and the use of cromolyn sodium within 4 weeks of enrollment into the study. Enrolled patients were instructed not to use ocular medications throughout the study. Patients in Group I received an Acuvue lens (etafilcon A with 58% water) in one eye and a SeeQuence lens (polymacon with 38.6% water) in the other eye. Group II received a NewVues lens (vifilcon A with 55% water) and a SeeQuence lens. Patients in Group III received an Acuvue lens in one eye and a NewVues in the other eye. All lenses were usedon a daily-wear basisfor a period of 1 month. A uniform systemof lens care was provided for each patient. The AOSEPT@ cleaning and disinfecting system and weekly Ultrazyme@ enzymatic applications were used. Patients were not specifically asked to discontinue contact lens use just before the commencement of the study. The diagnosisof GPC wasconfirmed at the initial meeting with each patient. An ocular and contact lens history wasobtained, and an examination wasperformed. Patient histories included the collection of data concerning the patients’ age, sex, years of soft contact lens use, yearssince diagnosisof GPC, the ageof their present lenses,the hours of contact lens use, their history of allergies, and their history of topical cromolyn sodium use. The everted upper lid was evaluated at the baseline examination and at the third and fifth follow-up visits. Papillae were ranked from 1 to 7 according to their size and distribution. The grading systemfor evaluating the papillae
Table 1. Patient Profileof GPC PatientsEnteringDisposable Contact LensStudy
Age Sex Yearsof soft contact lensuse Yearssincediagnosis of GPC Age of present contact lenses Hoursof contact use History of allergies History of topical cromolynsodiumuse
Average 31.0 years Range 19-39years Male, 11 Female,31 Average 7.3 years Range 2-16 years Average 2.1 years Range O-5 years Average 9 months Range 1 month-3 years Average 11.4hours Range G-20 hours 10%seasonal allergies 25%drug allegies(i.e. ( penicillin) 27%
on the everted upper lid wasthe following: Grade 1, normal examination; Grade 2, initial formation of macropapillae (0.3-1.0 mm); Grade 3, diffuse macropapillae (0.3-1.0 mm) and initial formation of giant papillae (larger than 1.0 mm); Grade 4, diffuse macropapillae (0.3-1.0 mm) and giant papillae (larger than 1.0 mm) covering most of the lower one-third of the everted upper lid; Grade 5, giant papillae (larger than 1.O mm) covering most of the lower two-thirds of the everted upper lid; Grade 6, diffuse giant papillae (larger than 1.0 mm); Grade 7, giant papillae (larger than 1.0 mm) observablewith the naked eye. Ocular examinations were performed by an independent masked examiner after the contact lenses had been removed. Patients were unaware that they were wearing disposablecontact lenses.The patient was informed that his or her lenseswere to be examined at each visit. A new disposablecontact lens was exchanged for the “old” lens before the lens casewas returned to the patient. One lens casewasusedfor the duration of the study. At each follow-up visit, a questionnaire called “a patient preference evaluation” was completed. This questionnaire tested patient preferenceswith regard to nine variables including itching, discharge, blurred vision, pain, abnormal lens movement, lens awareness,lens handling, lens comfort, and overall lens preference. Patients were given the choice of having no preference (Pref.) or a mild, moderate (Mod.), or strong preference for either contact lens. For example, the patient wasaskedto respondto the following statement: “With regardto itching, I prefer the Left Lens
SrAla
Mid.
Mild
?I” Prei.
5 Mdd
6 Mod.
.” 7 Strong
Rtght LSXS
After the patient had respondedto a similar statement for the first eight variables, overall lenspreference wasevaluated by having the patient respondto the following statement:
ICLC, Vol. 22, March/April
1995
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Clinical
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Table 2. Patient Preference Evaluation for Pooled Responses (All Follow-Up Preference response per Lens
Symptoms Itching
Acuvue SeeQuence No preference Acuvue SeeQuence No preference Acuvue SeeQuence No preference Acuvue SeeQuence No preference Acuvue SeeQuence No preference Acuvue SeeQuence No preference Acuvue SeeQuence No preference Acuvue SeeQuence No preference Acuvue SeeQuence No preference
Discharge
Blurred vision Pain Lens movement
Lens awareness Handling
Comfort Overall
25 10 23 10 6 42 16 14 28 16 16 26 4 19 35 15 23 20 5 26 27 17 21 21 25 12
Visits): Acuvue vs. SeeQuence (N = 58) (Group I) Mean’ Rank
Two-Tailed p Value
17.70 18.75
0.0371
Acuvue
08.10 09.17
0.501
-$
14.41 16.75
0.967
-4
14.81 18.19
0.614
-4
11.25 12.16
0.047t
SeeQuence
20.83 18.63
0.400
-4
14.10 16.37
0.001t
SeeQuence
21.62 17.79
0.965
4
24.45 22.70
0.768
-4
Preferred Lens
Wilcoxon matched-pairs signed-ranks test. t Significant. $ No significant difference between lenses. l
“Overall, Left Lens
with all things considered,
1 Strong
2 Mod.
3 Mild
4 No. Pref.
5 Mild
I prefer the . 6 Mod.
7 Strong
.” Right Lens
The data from the patient preference evaluations were analyzed both parametrically and nonparametrically. The Kolomogorov-Smirnov one-sampletest was used to assess the normal distribution of the data. The pooled data easily met the requirements of this test, whereasthe data from individual follow-up visits were borderline. The patient preference evaluation wasanalyzed for each group at every follow-up visit and in the aggregate. The more powerful parametric one-samplepaired t-test was applied to screen for significant differences in the data. The nonparametric Wilcoxon matched-pairssigned-rankstest wasthen usedto confirm the detection of true differences while meeting the strict criteria required with ordinal scaleddata. Multivariate regressionanalysis was also performed on the patient preference evaluation data. The first eight symptom characteristics acted as the independent variables, whereasoverall lens preference acted as the dependent variable. Numerous methods of analysis were applied to detect significant differences in the data regarding the examina-
82
ICE,
Vol. 22, March/April
1995
tion of the papillae of the everted upper lids. First, the data for each lens type for each individual group were compared at baseline, at the third follow-up visit, and at the final follow-up visit (5 months). Thus, nine paired-samples t-testswere completed, one t-test for each of three groupsat three different time periods. The parametric t-test wasthen followed by a nonparametric Wilcoxon test to confirm the results becausethe parametric tests are dependent on a normal distribution of the data. The examination data for each lens type from each group were analyzed for changesover time. The examination data were then restructured to allow analysisby lens type, irrespective of group. For example, the examination data for eyes wearing the Acuvue lens from Groups I and III were combined into one group of all eyes wearing the Acuvue lens. Thus, analysisin the aggregateto compare all “Acuvue eyes” with all “NewVues eyes” and “SeeQuence eyes” waspossible.A regressionwasperformed for each lens type to test the hypothesis that the slopeof the regressionline of papillae gradingsasa function of the time period waszero.
Results Randomization resulted in Group I (Acuvue YS. SeeQuence) having 12 patients, Group II (NewVues ets.
Disposable Contact Lenses in Patients With GPC: Bucci et al. Table 3. Patient Preference Evaluation Symptoms Itching
Discharge Blurred vision Pain
Lens movement Lens awareness Handling Comfort Overall
for Pooled Responses (All Follow-Up
Preference response per Lens SeeQuence NewVues No preference SeeQuence NewVues No preference SeeQuence NewVues No preference SeeQuence NewVues No preference SeeQuence NewVues No preference SeeQuence NewVues No preference SeeQuence NewVues No preference SeeQuence NewVues No preference SeeQuence Newvues No preference
20 31 21 15 18 39 23 27 22 16 27 29 18 18 36 27 30 15 27 17 28 23 35 14 24 36 12
Visits): SeeQeunce vs. NewVues
(N = 72) (Group II)
Mean’ Rank
Two-Tailed p Value
21.13 29.15
0.024t
14.43 19.14
0.252
-4
18.96 31.07
0.050t
NewVues
19.38 23.56
0.049t
NewVues
14.97 22.03
0.318
-4
25.17 32.45
0.242
-4
21.28 24.44
0.353
4
25.59 32.07
0.039t
NewVues
25.42 33.89
0.0251
NewVues
Preferred Lens NewVus
Wilcoxon matched-pairs signed-ranks test. t Significant. $ No significant difference between lenses. l
SeeQuence) having 15 patients, and Group III (NewVues vs. Acuvue) having 15 patients. The number of patients lost to follow-up wasnot a significant problem. No patients were lost to follow-up in Groups I and II until the last follow-up visit. Only two patients in Group I and three patients in Group II were not evaluated at the last followup visit. No patients were lost to follow-up in Group III through three visits. Two patients were lost to follow-up at Visit 4, and one was lost to follow-up at Visit 5 in Group III. Patient profiles are summarizedin T&k 1. Trends toward correlations between both the age of the present contact lens and the hours of contact lens usewith the severity of symptoms were observed, but significance was not demonstrated. No episodesof acute GPC were observedthroughout the study. There were no episodesthat necessitatedthe useof topical medications. The total number of tom contact lenseswas nine for the Acuvue, two for the SeeQuence, and five for the NewVues. The patient preference evaluations revealed significant differences between lensesin all three groups. Pooled data from all follow-up visits in Group I (Acuvue versus SeeQuence) showed mixed results (Table 2). The Acuvue
wassignificantly preferred to the SeeQuencefor itching (p = 0.037). For abnormal lens movement (p = 0.047) and lens handling (p = O.OOl), the SeeQuence was significantly preferred to the Acuvue. There was no significant difference for overall lens preference between the Acuvue and SeeQuencelenses.The preference for the SeeQuence lens with regard to handling wasalsodetected at numerous individual visits. The patients in Group II (SeeQuence vs. NewVues) for the pooled data significantly preferred the NewVues lens for four of eight variables and for overall lenspreference (p = .025) (Table 3). The four variables for which the NewVues lens was preferred were itching (p = 0.024), blurred vision (p = O.OSO),pain (p = 0.049), and lens comfort (p = 0.025). These differences were also detected in the analysisof early individual follow-up visits. Group II wasthe only paired study that revealed a significant difference for the overall lens preferencevariable (NewVues preferred to SeeQuence). The patients in Group III (Acuvue vs. NewVues) significantly preferred the NewVues lenswith regardto lens handling (p = 0.024) in th e analysisof the pooled data (Table 4). No significant difference for overall lens preference was detected between the Acuvue and NewVues lenses.
ICLC, Vol. 22, March/April
1995
83
Clinical Article Table 4. Patient Preference Evaluation for Pooled Responses (All Follow-Up Preference response per Lens
Symptoms Itching
AcuVue NewVues No preference AcuVue NewVues No preference AcuVue NewVues No preference AcuVue NewVues No preference AcuVue NewVues No preference AcuVue NewVues No preference AcuVue NewVues No preference AcuVue NewVues No prefernce AcuVue NewVues No preference
Discharge Blurred vision Pain Lens movement Lens awareness Handling
Comfort Overall
Visits): Acuvue vs. NewVues
(N = 70) (Group III)
Mean’ Rank
Two-Tailed p Value
Preferred Lens
13.14 15.38
0.183
--.j
10.72 08.28
0.632
-3
19.62 18.19
0.361
-4
19.23 14.63
0.793
-4
16.75 11.24
0.443
-4
19.09 17.08
0.876
-4
09.42 18.94
0.024t
NewVues
15
23.55 19.80
0.960
-4
:: 22 23 25
28.30 23.79
0.676
--$
8 14 48 6 6 58 18 13 39 10 16 44 5 14 51 13 16 41 9 :::
* Wilcoxon matched-pairs signed-ranks test. t Significant. $ No significant difference between lenses. Multivariate
regression
analysis
revealed
that,
of the
eight variables tested, lens comfort and lens handling contributed significantly to the choice for overall lens preference in all three paired studies (T&b 5). The regression coefficients indicated that lenscomfort wasat leasttwice as powerful as lens handling in all cases.For the Acuvue 01s. NewVues study (Group III), in addition to lens comfort (0.60) and lens handling (0.30), four other variables were detected assignificantly contributing to the choice of overall lens preference. The four variables and their regression coefficients were blurred vision (0.30)) pain (0.22)) abnormal lens movement (0.24), and lens awareness(0.22). In summary, the NewVues outperformed the SeeQuence in five of nine clinical categories, including overall lens preference. When the Acuvue was compared with the SeeQuence, the SeeQuence was preferred for lens movement and lens handling, whereasthe Acuvue waspreferred with regard to itching. The NewVues outperformed the Acuvue in only one category-lens handling. Lenscomfort wasclearly the most powerful variable contributing to overall lens preference, followed most consistently by lens handling. It should be noted that the SeeQuence lens was outperformed with regard to itching in both paired studies. Similarly, the Acuvue wasoutperformed with regard to lens
84
ICLC, Vol. 22, March/April
1995
handling in both of its paired studies. The NewVues lens wasnever outperformed. The frequency of papillae gradingsfor each lens type is summarizedin Table 6. No significant changesin the papillae were observed between lens types at any follow-up visit or over time within each group of lenses.Nine pairedsamplest-tests representinga comparison of gradingsof papillae for each pair of lenses in the three groups at the baseline, 3-month, and 5month evaluations showed no significant differences. These data are summarizedin Tubk 7. These nine groups of ordinal scaled data were then reanalyzed by the use of a nonparametric test called the Wilcoxon matched-pairs signed-rankstest. This test also revealed no significant differences in papillae gradingsbetween lens types at all time periods, and the p values for each Wilcoxon test is given in Table 7 adjacent to the p values for the paired-samplest-tests. The nonparametric three-sample Friedman two-way analysis of variance was used to analyze changes in the papillae gradingsover time for each lens type within each group. Six analysesrepresenting two lens types for each of three groupsrevealed no significant changesover time for any of the six groupstested. The gradingsof papillae were then analyzed by lenstype,
Disposable Contact Lenses in Patients With GPC: Bucci et al. Table 5. Multivariate Regression Analysis for Symptom Variables (Independent Variable) Contributing to the Choice of Overall Lens Preference (Dependent Variable) Group I (Acuvue ws. SeeQuence) Symptom Variables Itching Discharge Blurredvision Pain Lensmovement Lensawareness Lenshandling Lenscomfort
Regression Coefficient
Group II (SeeQuence vs. NewVues) Regression Coefficient
p Value
l
*
0.571
0.0046
0.36t
0.0008
*
-
.
-
l
.
l
*
*
p Value
l
-
.
0.0434
* -
.
0.0381 o.c315 0.0001 0.0001
0.24t l 0.22t
0.27t
O.oool 0.0001
0.54t
0.16t 0.93t
0.0004
0.30t
0.0001
0.60-f
.
- * 0.0001
0.30-f 0.22t
- .
.
-
-
- t
l
l
- *
-
-
Regression Coefficient
p Value
- *
l
Group III ( Acuvue vs. NewVues)
Regression coefficientnot significant. t Regression coefficient indicatesstatisticallysignificantcontribution to the choiceregardingoverall lenspreference. l
Table 6. FrequencyDistributionof PapillaeGradingson EvertedUpperLidsat the Baseline,3-Month, and Final (5-Month) Followup Evaluations Frequencyof PapillaeGradings(%) Lens Twe
Time Period
Grade 1
Grade
Grade
Grade
Grade
Grade
Grade
2
3
4
5
6
7
Mean
SD
SE
Groups
Acuvue Acuvue Acuvue
Baseline 0 (0) 3 months 0 (0) 5 months 0 (0)
0 (0) 0 (0) 0 (0)
1 ( 3.7)
14 (51.9)
6 (22.2)
6 (22.2)
0 (0)
4.63
0.88 0.17
4 (14.8)
10 (37.0)
8 (29.6)
5 (18.5)
0 (0)
4.52
0.98
1 ( 4.5)
11 (50.0)
8 (36.4)
2 ( 9.1)
0 (0)
4.50
0.74 0.16
NewVues NewVues NewVues
Baseline 0 (0) 3 months 0 (0) 5 months 0 (0)
0 (0) 0 (0) 0 (0)
8 (26.7) 8 (26.7) 8 (33.3)
11 (36.7)
7 (23.3)
14 (46.7) 8 (33.3)
5 (16.7) 6 (25.0)
4 (13.3) 3 (10.0)
0 (0) 0 (0)
4.23 4.10
1.00 0.18 0.92 0.17
2 ( 8.3)
0 (0)
4.08
0.97
SeeQuence Baseline 0 (0) SeeQuence 3 months 0 (0) SeeQuence 5 months 0 (0)
0 (0) l(3.7) 0 (0)
5 (18.5)
10 (37.0) 12 (44.4)
8 (29.6) 5 (18.5)
3 (11.1) 4 (14.8)
l(3.7) 0 (0)
4.44
1.05 0.20
4 (18.2)
3 (13.6)
0 (0)
4.22 4.18
1.05 1.05
5 (18.5) 6 (27.3)
9 (40.9)
0.19
0.20 0.20 0.20
I & III I &III I&III II & III 11& III II & III I &II I & II I & II
SD, standarddeviation; SE, standarderror. irrespective of their original group. Nonrepeated and repeatedmeasuresanalysisof variance rejected the hypothesis that significant differences in the meansof papillae gradings between the groups were present. To test for significant changes over time in these three aggregated lens type groups, a regressionanalysis of papillae gradings against time wasperformed for the three lenstypes. The hypothesis that the slopeof the regressionline of papillae gradingsas a function of time is zero was accepted for all three lens groups.
Discussion Although the exact causeof GPC is still unclear, recent studieshave strongly suggestedthat at least two relatively independent pathophysiologic factors are present. First, ocular immune responsesin monkeys wearing lensesfrom patients with GPC suggestthat someantigenic factor in the lens coating induces an immune reaction.2 Second, physical trauma of conjunctival cells induced by contact lenses hasbeen shown to stimulate the releaseof neutrophil che-
motactic factors. 3v4 Symptoms, such as abnormal lens movement, lens awareness,and discomfort on insertion, appear to be closely linked to the physical properties of lenses(i.e., edgedesigns)and their mechanical interaction with the ocular surface and palpebral conjunctiva. The prominent symptom of itching in GPC hasbeen shown to dramatically improve with the introduction of a fresh lens of almost any type, even in the setting of worsening mechanically related symptoms.6These clinical observations support the concept of a multifactorial pathophysiology in GPC. The useof frequent lens replacement and daily lens hygiene in this study minimizes the potential development of symptomatic GPC secondary to the accumulation of contact lens deposits. Thus, this comparative clinical assessment emphasizesthe relationship between the physicalmechanicalproperties of each lens and their ability to function on an ocular surfacepreviously complicated by GPC. The resultsof this study suggestthat the NewVues lens is the disposablelens of choice for patients with GPC. The ICLC, Vol. 22, March/April
1995
85
Clinical
Article
Table 7. Statistical Comparison Time Period Baseline
3 months
5 months
Baseline
3 months
5 months
Baseline
3 months
5 months
Lens Type
of Papillae Gradings Within Group
Each Group at Baseline, 3 Months, and 5 Months
No. of Patients
Mean
Acuvue
1
12
4.67
SeeQuence
I
12
4.42
Acuvue
I
12
4.42
SeeQuence
I
12
4.25
Acuvue
I
10
4.60
SeeQuence
I
10
4.10
SeeQuence
II
15
4.47
NewVues
II
15
4.20
SeeQuence
II
15
4.20
NewVues
II
15
3.93
SeeQuence
II
12
4.25
NewVues
II
12
4.00
Acuvue
III
15
4.60
NewVues
III
15
4.27
Acuvue
III
15
4.60
NewVues
III
15
4.27
Acuvue
III
12
4.42
NewVues
III
12
4.17
Mean Difference
SD
0.25
1.06
0.43’
(Wilcoxon
= 0.39t)
0.17
1.20
0.64
(Wilcoxon
= 0.78)
0.50
0.97
0.14
(Wilcoxon
= 0.16)
0.27
1.53
0.51
(Wilcoxon
= 0.55)
0.27
1.28
0.43
(Wilcoxon
= 0.41)
0.25
1.36
0.54
(Wilcoxon
= 0.39)
0.33
1.11
0.26
(Wilcoxon
= 0.28)
0.33
1.23
0.31
(Wilcoxon
= 0.30)
0.25
0.97
0.39
(Wilcoxon
= 0.40)
Two-Tailed
p Value
SD, standard deviation. * p value from paired-samples c-tests (parametric). 7 p value from Wilcoxon matched-pairs signed-ranks test (nonparametric). NewVues
lens only
narrowly
outperformed
the Acuvue
lens, and there wasno significant difference for the overall lens preference variable. The clinical performance of the Acuvue lens suggests that a significant number of patients encountered difficulties when trying to manipulate this lens. This is consistent with a previous study that compared the Acuvue lens with the CSI lens in GPC patients. ’ The CSI lenswaspreferred to the Acuvue lens with regard to handling (78 VS.6%) for those patients having a preference. Multivariate regression analysis identified lens handling as a significant variable contributing to overall lens preference in both the CSI study and this study. For this investigation, lens handling was a significant independent variable in all three paired studies. Its power as an independent variable was second only to lens comfort. Although someclinicians may argue that lens handling has no direct relationship with the clinical syndrome of GPC, we believe that this variable may play an important 86
ICE,
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role and should be studied. It is well known that GPC patients should not wear contact lenseson an extendedwear basis.Thus, disposablelenses,which were originally designedasextended-wear lenses,are frequently being used on a daily-wear basisin patients having GPC. Excessive lens manipulation can lead to accelerated soiling of soft contact lenses.Substancesfrom the skin may increasethe antigenic load on the contact lens. Difficulties with lens handling may influence the overall compliance with the practice of quality lens hygiene. Effective lens hygiene is critical in patients with GPC, even when they are wearing disposablelensesfor relatively short wearing intervals. Lenshandling may also influence the rate of tom lenses for each lens type. If we assumethat difficulties with lens handling correlate with increasedrates of tom lenses,then the relatively higher number of tom Acuvue lensesreported in this study is not surprising. Clinicians and patients have both reported that the excessive flexibility of the Acuvue lens can frequently obscure its proper orienta-
Disposabk Contact Lenses in Patients With GPC: Bwci et al. tion before insertion. This characteristic of the Acuvue lens is probably responsiblefor its relatively poor performance with regard to lens handling and the rate of tom lenses.
References 1. Allansmith
MR, Korb DR, Greiner JV, et al. : Giant papillary conjunctivitis in contact lens wearers. AmJ Ophthulmol 1977; 83~697-708. 2. Ballow M, Donshik PC, Rapacy P, et al. : Immune responses in monkeys to lenses from patients with contact lens induced giant papillary conjunctivitis. CLAO 1989; 15&l-70. 3. Ehlers WH, Donshik PC, Gillies C, et al.: The induction of an inflammatory reaction (similar to giant papillary conjunc-
Clinical
tivitis) by chemotactic factors derived from conjunctival cells. ARVO abstract. Invest Ophthulmol Vis Sci 1990;3 I:
(Suppl):241. 4. Elgebaly SA, Donshik PC, Rahhal F, Williams W: Neutrophi1 chemotactic factors in the tears of giant papillary conjunctivitis patients. Invest Ophthalmol Vis Sci 1991;32:208213. 5. Bucci FA Jr, Lopatynsky MO, Jenkins PL, et ~2.: The Acuvue disposable contact lens versus the CSI contact lens in patients with giant papillary conjunctivitis. Am ] Ophthdmol 1993;115:454-459. 6. Bucci FA, Jr, Lopatynsky MO, Jenkins PL, et al. : The deposit resistant Hydrocurve Elite soft contact lens and giant papillary conjunctivitis. ARVO abstracts. Invest Ophthulmol Vis Sci 1989;3O(Suppl):256.
Implications
Disposablecontact lensesworn on a daily-wear basisand replaced every 1 to 2 weeks appear to be effective in managing patients with giant papillary conjunctivitis (GPC). Reducing the protein-related antigens from contact lens deposits and minimizing conjunctival trauma from contact lens wear are reasonablestrategiesfor managing GPC. This article attempts to show that one brand of disposablecontact lens is best in managing GPC. Statistics may show that one brand is preferable; however, clinical performance does not seem to be significantly enhanced by the use of one brand of disposableover the others. The lenseswere usedin a non-Food and Drug Administration-approved method; therefore, the clinical implication may not be asobvious asthe statistics indicate. Knowledge of this researchmay be valuable to keep in mind when selecting a lens for your patient.
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Clinical A&k Peter Zloty, MD, is a cornea and external disease specialist currently in private practice in Dothan, AL. He received his medical degree from the Albany Medical College of Union University in Albany, NY. After a medical internship in Albany, he served 3 years as an emergency medicine physician in the United States Navy. Dr. Zloty completed his ophthalmology residency and cornea1 fellowship at the Albany Medical Center in Albany. His cornea1 fellowship was under the direction of Michael W. Belin, MD, and emphasized local and systemic immunosuppression in cornea1 transplantation and ocular inflammatory diseases. He has published two book chapters in ocular infectious diseases. Marta 0. Lopatynsky, MD, is currently the cornea and external disease specialist at Bassett Health Care in Cooperstown, NY. She received a cum laude degree from New York University, received her masters degree from Albany Medical College, and completed an internship and residency at Albany Medical Center. Her fellowship in cornea and external disease was completed at Wills Eye Hospital in Philadelphia. She has received a number of awards including the Outstanding Research Award in 1988 and, in 1990, the CLAO first prize for clinical research. She has authored several articles on contact lens use and penetrating keratoplasties. Frank A. Bucci, Jr., MD, is currently the director of the Center for Contact Lens Research in Kingston, PA. He originally attended Rollins College on a basketball scholarship. He received a masters in health care administration from Cornell University. Dr. Bucci completed his ophthalmology residency at Albany Medical College in Albany, NY. He received his fellowship training in cornea1 transplantation, small incision cataract surgery, and refractive surgery under the direction of Richard L. Lindstrom, MD, at the University of Minnesota. Dr. Bucci was awarded Best Scientific Presentation at the Annual Meeting of the Contact Lens Association of Ophthalmology (CLAO) in 1990 and 1994. He has authored over 25 original publications in peer review journals.
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